# FDA 483 - Nutravail, LLC. - February 06, 2020

Source: https://www.globalkeysolutions.net/records/483/nutravail-llc/6709cd8f-9d36-42db-a94b-d65adc8f50f7

> FDA 483 for Nutravail, LLC. on February 06, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nutravail, LLC.
- Inspection Date: 2020-02-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Nutravail, LLC, a drug manufacturer in Chantilly, VA, was cited for two significant observations during an FDA inspection. The firm failed to exercise appropriate controls over computer systems used for critical analyses, allowing unauthorized changes and inadequate audit trail review. Additionally, the company accepted supplier analyses for components without adequately establishing the reliability of those analyses, leading to the use of out-of-specification materials.

## Related Officers

- [Supervisory Consumer Safety Officer, China Office](https://www.globalkeysolutions.net/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)
- [Kathleen M. Jordan](https://www.globalkeysolutions.net/people/kathleen-m-jordan/e08b786a-47bf-4e78-ae96-9d94cdc20bdb)

Company: https://www.globalkeysolutions.net/companies/nutravail-llc/cda316e9-fdbd-4f8a-8fff-dc6be68c0c85

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e